MSAT Validation & Lifecycle Lead, Cell Therapy

Biopharma Careers; Leiden; Hybrid; EUR 110,000 - 150,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Bristol Myers Squibb Leiden Cell Therapy Facility seeks a Manager, MSAT Validation & LCM to lead validation activities, lifecycle management, and risk assessments for advanced cell therapy manufacturing. The role interfaces with process engineers and regulatory teams to ensure quality and compliance.

The ideal candidate has extensive biopharma validation experience, strong communication skills, and a track record of driving improvements in GMP environments.

Qualifications

• Proficient in cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Experience in facility/clean room design, process, equipment, automation, and validation.
• Experience in assessing and implementing product lifecycle changes.
• Experience with internal and health authority audits, particularly pre-licensure inspections (PLIs).
• Excellent verbal/written communication skills and ability to influence at all levels.

Responsibilities

• Lead validation activities for new products or processes related to the facility.
• Responsible for CTF Process Validation activities including APS/APV and PPQ.
• Perform data analysis and prepare protocols/reports supporting validation studies.
• Design and execute test plans and risk mitigation activities for validation investigations.
• Interface with process engineers and serve as validation SME.
• Lead site implementation of Lifecycle Management changes.
• Support equipment and facility commissioning, qualification and validation.
• Lead/Own site Change Controls.
• Participate in risk assessments and author qualification/validation documents.
• Support investigations and global change controls as required.
• Ensure safe and compliant cGMP operations and regulatory inspections readiness.
• Identify and drive continuous improvements to reduce risks and costs across production.

Skills

cGMP knowledge

Biopharma operations

Facility/clean room design

Process validation

Audit experience

Communication skills

Education

Bachelor's degree in science/engineering/biochemistry

Advanced degree preferred

Job description

Bristol Myers Squibb Leiden Cell Therapy Facility seeks a Manager, MSAT Validation & LCM to lead validation activities, lifecycle management, and risk assessments for advanced cell therapy manufacturing. The role interfaces with process engineers and regulatory teams to ensure quality and compliance.

The ideal candidate has extensive biopharma validation experience, strong communication skills, and a track record of driving improvements in GMP environments.